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Addressing Unmet Medical Needs in Type 1 Diabetes: A Review of Drugs Under Development.


ABSTRACT: The incidence of type 1 diabetes (T1D) is increasing worldwide and there is a very large need for effective therapies. Essentially no therapies other than insulin are currently approved for the treatment of T1D. Drugs already in use for type 2 diabetes and many new drugs are under clinical development for T1D, including compounds with both established and new mechanisms of action. Content of the Review: Most of the new compounds in clinical development are currently in Phase 1 and 2. Drug classes discussed in this review include new insulins, SGLT inhibitors, GLP-1 agonists, immunomodulatory drugs including autoantigens and anti-cytokines, agents that regenerate ?-cells and others. Regulatory Considerations: In addition, considerations are provided with regard to the regulatory environment for the clinical development of drugs for T1D, with a focus on the United States Food and Drug Administration and the European Medicines Agency. Future opportunities, such as combination treatments of immunomodulatory and beta-cell regenerating therapies, are also discussed.

SUBMITTER: Mittermayer F 

PROVIDER: S-EPMC5748875 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature

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Addressing Unmet Medical Needs in Type 1 Diabetes: A Review of Drugs Under Development.

Mittermayer Friedrich F   Caveney Erica E   De Oliveira Claudia C   Fleming G Alexander GA   Gourgiotis Loukas L   Puri Mala M   Tai Li-Jung LJ   Turner J Rick JR  

Current diabetes reviews 20170101 3


<h4>Introduction</h4>The incidence of type 1 diabetes (T1D) is increasing worldwide and there is a very large need for effective therapies. Essentially no therapies other than insulin are currently approved for the treatment of T1D. Drugs already in use for type 2 diabetes and many new drugs are under clinical development for T1D, including compounds with both established and new mechanisms of action. Content of the Review: Most of the new compounds in clinical development are currently in Phase  ...[more]

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